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onyx ii finger pulse oximeter model 9550

Nonin Medical

Summary: The Onyx II Finger Pulse Oximeter by Nonin Medical is a portable device used to measure peripheral oxygen saturation (SpO2) levels. It is commonly used by healthcare providers in various settings to quickly assess a patient's oxygenation status.

FDA Clearance Information

Pathway 510K
Decision Date January 11, 2006
Product Code DQA
Device Class Class 2
Evidence 40 studies

The Onyx II Finger Pulse Oximeter was cleared via the FDA 510(k) pathway on January 11, 2006. It is manufactured by Nonin Medical and classified as a Class 2 device under product code DQA.

What It Is

The Onyx II Finger Pulse Oximeter is a compact, non-invasive device designed to measure the oxygen saturation level in a patient's blood. It works by emitting light through the fingertip and measuring the amount of light absorbed by oxygenated and deoxygenated hemoglobin. This device provides immediate feedback on a patient's respiratory status, which is crucial in various medical settings.

Clinical Applications

This pulse oximeter is widely used in emergency departments, operating rooms, and by paramedics in pre-hospital settings. It is essential for monitoring patients with respiratory or cardiac conditions, during anesthesia, or in critical care units. The device is also useful for assessing patients with chronic conditions like COPD or during sleep studies to monitor oxygen levels.

Indications for Use

The Onyx II is indicated for use in measuring blood oxygen levels in patients who may be experiencing respiratory distress or other conditions affecting oxygenation. It is suitable for both acute and chronic monitoring of oxygen saturation in various patient populations.

Practical Considerations

The Onyx II is designed to fit a wide range of finger sizes, making it versatile for use in both adults and children. It is battery-operated and portable, allowing for easy transport and use in multiple settings. Clinicians should ensure proper placement on the finger for accurate readings.

Related Literature

The linked study compared the accuracy of handheld and finger-based pulse oximeters under different motion and environmental conditions. It found that while both types of devices are generally reliable, their accuracy can be affected by external factors such as movement and ambient conditions. The study highlights the importance of considering these variables when interpreting pulse oximetry readings.

Linked Studies (20)

PubMed • 2026

Peripheral Vasculature Embolization with the Onyx Liquid Embolic System in a Swine Model.

Journal of vascular and interventional radiology : JVIR

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Embolization of middle meningeal artery for chronic subdural hematoma: Do we have sufficient evidence?

Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences

View Source →
PubMed • 2025

Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.

Journal of neuroendovascular therapy

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2024

Rationale and design of INFINITY-SWEDEHEART: A registry-based randomized clinical trial comparing clinical outcomes of the sirolimus-eluting DynamX bioadaptor to the zotarolimus-eluting Resolute Onyx stent.

American heart journal

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2024

OnyxTMGel or Coil versus Hydrogel as Embolic Agents in Endovascular Applications: Review of the Literature and Case Series.

Gels (Basel, Switzerland)

View Source →
PubMed • 2024

The resolute Onyx in TIA management (ROTIA).

Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2024

Spinal tumor embolization with Onyx: A systematic review and meta-analysis.

Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2024

Technical video: Onyx-18 embolization of spinal epidural arteriovenous Fistula using the scepter-Mini balloon catheter.

Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2023

DynamX sirolimus-eluting Bioadaptor versus the zotarolimus-eluting Resolute Onyx stent in patients with de novo coronary artery lesions: Design and rationale of the multi-center, international, randomized BIODAPTOR-RCT.

Cardiovascular revascularization medicine : including molecular interventions

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2023

Delayed Migration of Onyx Embolic Agent after Preoperative Embolization of an Arteriovenous Malformation in a Pediatric Patient: A Case Report and Review of the Literature.

Pediatric neurosurgery

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2023

The Era of Onyx Embolization: A Systematic and Literature Review of Preoperative Embolization Before Stereotactic Radiosurgery for the Management of Cerebral Arteriovenous Malformations.

World neurosurgery

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2023

Torcular dural AVF: Transvenous onyx embolisation with sinus reconstruction.

Clinical neurology and neurosurgery

View Source →
PubMed • 2023

Retrieval of a Fractured Marathon Microcatheter Entrapped in Onyx Using a Novel Stentriever-Assisted Technique.

Operative neurosurgery (Hagerstown, Md.)

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2022

Onyx™ Cast Fragmentation After Embolization of Endoleaks.

Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2022

Comparative Evaluation of Conventional and OnyxCeph™ Dental Software Measurements on Cephalometric Radiography.

Turkish journal of orthodontics

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2021

Dosimetric comparison of iPlanⓇ Pencil Beam (PB) and Monte Carlo (MC) algorithms in stereotactic radiosurgery/radiotherapy (SRS/SRT) plans of intracranial arteriovenous malformations.

Medical dosimetry : official journal of the American Association of Medical Dosimetrists

Retrospective View Source →
PubMed • 2021

Transradial middle meningeal artery embolization for chronic subdural hematoma using Onyx: case series.

Journal of neurointerventional surgery

Case Series View Source →
PubMed • 2020

Percutaneous transorbital embolization of a carotid cavernous fistula.

Proceedings (Baylor University. Medical Center)

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2020

Comparison of short-term clinical outcomes between Resolute Onyx zotarolimus-eluting stents and everolimus-eluting stent in patients with acute myocardial infarction: Results from the Korea Acute Myocardial infarction Registry (KAMIR).

Cardiology journal

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2020

Device profile of the Resolute Onyx Zotarolimus eluting coronary stent system for the treatment of coronary artery disease: overview of its safety and efficacy.

Expert review of medical devices

RCT|prospective|retrospective|case Series|other View Source →

Frequently Asked Questions

What is the Onyx II Finger Pulse Oximeter used for?

It is used to measure peripheral oxygen saturation (SpO2) levels in patients, providing quick and non-invasive assessment of their oxygenation status.

What specialties typically use this device?

Emergency medicine, anesthesiology, critical care, pulmonology, and paramedics commonly use this device.

What are the FDA-cleared indications?

The device is indicated for measuring blood oxygen levels in patients with conditions affecting oxygenation, suitable for both acute and chronic monitoring.

Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference. It does not constitute medical advice, product endorsement, or a recommendation for clinical use. Always consult manufacturer documentation and clinical judgment for patient care decisions.

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